Actively Recruiting
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-29
240
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
CONDITIONS
Official Title
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a clinical diagnosis of elbow epicondylitis
- Symptoms lasting longer than 3 months
- Ultrasound evidence of radial extensor carpal tendinopathy
- Age greater than 18 and less than 65 years
- Both men and women
- Persistent symptoms despite at least 3 months of conservative treatment
- Hemoglobin level above 11 g/dl
- Platelet count greater than 150,000 plt/mm3 from recent blood test
- Negative blood tests for HBsAg, HCV antibodies, and HIV-1-2 antibodies
- No significant changes on recent electrocardiogram (ECG)
- Ability and willingness to participate in follow-up visits
- Signed informed consent form
You will not qualify if you...
- Previous surgery on the epicondylar tendons
- Received epicondylar injections in the past 6 months
- Unable to participate in follow-up visits
- Incapacitated individuals
- Immunodeficiency conditions
- Fibromyalgia diagnosis
- Active systemic inflammatory diseases (unless stabilized)
- Uncontrolled thyroid metabolic disorders
- Alcohol, drug, or medication abuse
- Use of NSAIDs within 3 days before blood collection
- Coagulation problems or ongoing antiplatelet therapy that cannot be stopped
- Cardiovascular disease making 300 mL blood draw unsafe
- Positive blood tests for HBsAg, HCV antibodies, or HIV-1-2 antibodies
- Other current elbow diseases such as osteoarthritis, epitrochleitis, or stiff elbow
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
E
Enrico Guerra, MD
CONTACT
R
Roberta Licciardi, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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